Trial website

Contact information

Type

Primary contact

ORCID ID

Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

DECIDE

Study hypothesis

To determine whether, in children with newly diagnosed diabetes who are not acutely unwell, it is better to admit to hospital for initiation of insulin treatment and education of child and family, or whether results would be better if initial management was provided at home.

Study design

Primary study design

Secondary study design

Trial setting

Trial type

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Type 1 diabetes

Intervention

Patients will be randomised to either:1. Home management 2. Hospital managment

Patients and their parents will be randomised on the day of diagnosis to receive their diabetes treatment from home or from hospital. Patients in the Hospital Management Group will be admitted for a minimum of three nights (receiving at least six supervised injections while hospitalised). Patients in the Home Management Group will be discharged home on day of diagnosis and treatment and support will be delivered at home for a minimum of three days (at least six supervised injections). All patients will receive the same care and at their 1, 12 and 24 month clinic visits follow-up data will be collected and when the patients HbA1c is being tested, extra blood will be taken to be sent off for HbA1c analysis at a central laboratory. At 1, 12 and 24 months post diagnosis patients aged greater than or equal to 8 years old and all parents will be asked to complete a questionnaire to assess psychological, social, physical or economic outcomes of home or hospital management. Children with type 1 diabetes have traditionally been hospitalised at diagnosis but are increasingly starting treatment at home. There is no high-quality evidence regarding psychological, social, physical or economic outcomes of home or hospital management.

Overall trial start date

01/01/2008

Overall trial end date

01/01/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children aged 0 - 17 years old 2. Newly diagnosed type 1 diabetes (using recognised standard diagnostic criteria) who are clinically well (pH greater than 7.29) at presentation3. Written informed consent given by parent(s)/carer/child and assent from child4. Able to fill out study material (all parents and children aged greater than or equal to 8 years old)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

240

Participant exclusion criteria

1. Children with a coexisting chronic disorder (e.g., cystic fibrosis) which will impact significantly on blood glucose control2. Children with type 2 diabetes3. Children with Maturity Onset Diabetes of the Young (MODY)4. Children with an uncertain diagnosis5. Children who are under the care of the local authority6. Children whose home circumstances are assessed as being unsuitable for home management7. Children who require hospitalisation for reasons other than their diagnosis